Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000667213
Ethics application status
Approved
Date submitted
11/09/2008
Date registered
6/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Father Infant Feeding Initiative: Increasing breastfeeding initiation and duration via education and social support for fathers.
Scientific title
Father Infant Feeding Iniative, breastfeeding, initiation and duration of breastfeeding.
Universal Trial Number (UTN)
Trial acronym
FIFI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding duration 3678 0
Condition category
Condition code
Public Health 3842 3842 0 0
Health promotion/education
Diet and Nutrition 239763 239763 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Male subjects attend the standard antenatal education classes plus an additional one hour class on breastfeeding and the role of fathers. This session is delivered in hospital by trained male facilitators to fathers allocated to the intervention group, social support and postnatal education (weekly via telephone, mail or email to week 6) screening (week 6 for postnatal depression)
Intervention code [1] 3389 0
Prevention
Intervention code [2] 3390 0
Behaviour
Comparator / control treatment
Standard treatment (standard antenatal education) Standard antenatal education refers to the current hospital standard, which varies between hospital. Generally they consist of 3-4 hours of in-hospital education delivered by hospital trained antenatal educators who are midwives. Content includes classes on the birth, a ward tour, and caring for the baby.
Control group
Active

Outcomes
Primary outcome [1] 4740 0
to increase by 10% the percent of mothers still breastfeeding. This will be measured at 6 weeks and at 6 months post birth via a self administered questionnaire.
Timepoint [1] 4740 0
6 weeks and 6 months post birth.
Secondary outcome [1] 8008 0
to increase father's positive attitude to breastfeeding as measured by the Iowa attitude scale
Timepoint [1] 8008 0
week 1, week 6 postbirth, 6 months postbirth.
Secondary outcome [2] 8009 0
to reduce anxiety and depression in new fathers as measured by the hospital anxiety and depression scale
Timepoint [2] 8009 0
week 1, week 6 postbirth, week 24 postbirth

Eligibility
Key inclusion criteria
fathers are intending to be involved in the raising of their baby and are contactable by phone, email or mail, mothers are intending to breastfeed, both parents can read English.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
not intending to breastfeed, not intending to be involved in the care of the baby, uncontactable, not able to read English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all expectant mothers and fathers enrolled in antenatal classes in 7 hospitals, randomised by hospital and then by class, allocation was determined by coin tossing with the person being unaware of which group the subjects would be allocated to. All parents complete the standard classes and those allocated to the intervention group also receive the additional antenatal class. Exclusion is determined after the analysis of baseline data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1146 0
6102
Recruitment postcode(s) [2] 1147 0
6107
Recruitment postcode(s) [3] 1148 0
6112
Recruitment postcode(s) [4] 1149 0
6160
Recruitment postcode(s) [5] 1150 0
6168
Recruitment postcode(s) [6] 1151 0
6027
Recruitment postcode(s) [7] 1152 0
6018
Recruitment postcode(s) [8] 1153 0
6111

Funding & Sponsors
Funding source category [1] 3857 0
Charities/Societies/Foundations
Name [1] 3857 0
Healthway
Country [1] 3857 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Po Box U 1987
Perth 6845
Western Australia
Country
Australia
Secondary sponsor category [1] 3463 0
None
Name [1] 3463 0
Address [1] 3463 0
Country [1] 3463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5911 0
Curtin University Ethics Committee
Ethics committee address [1] 5911 0
Ethics committee country [1] 5911 0
Australia
Date submitted for ethics approval [1] 5911 0
Approval date [1] 5911 0
15/12/2006
Ethics approval number [1] 5911 0
HR 163/2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28922 0
Address 28922 0
Country 28922 0
Phone 28922 0
Fax 28922 0
Email 28922 0
Contact person for public queries
Name 12079 0
Jenny Tohotoa
Address 12079 0
Po Box U 1987
Perth 6845
Western Australia
Country 12079 0
Australia
Phone 12079 0
+61 8 9266 4739
Fax 12079 0
Email 12079 0
[email protected]
Contact person for scientific queries
Name 3007 0
Prof Bruce Maycock
Address 3007 0
Po Box U 1987
Perth 6845
Western Australia
Country 3007 0
Australia
Phone 3007 0
+61 8 9266 7988
Fax 3007 0
Email 3007 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.